CAMBRIDGE, England—Phico Therapeutics Ltd recently announced that it has been awarded significant funding to support the manufacturing development of its intravenous antibiotic, SASPject PT3.8. Innovate UK, the UK’s innovation agency, will provide £1.4 million ($1.87 million USD) to support the project, which will be undertaken in partnership with The Clinical Trial Company and GE Healthcare.

Phico is developing SASPject PT3.8, an antibacterial therapy for the systemic treatment of patients with serious Pseudomonas aeruginosa (P. aeruginosa) infections, which have a high mortality rate. P. aeruginosa causes a wide range of infections, most frequently in hospitals, and is very difficult to treat, due to the bacteria’s intrinsic antibiotic resistance mechanisms, including an impermeable cell membrane and efflux pumps, which can remove antibiotics that do enter the cell. As clinical trials are expanded, it is anticipated that the product will also be used in situations where a P. aeruginosa infection is suspected but yet to be confirmed, further extending the market opportunity for SASPject PT3.8.

“Phico Therapeutics is pioneering a radical approach to antibacterial therapy which it believes could form the basis of a solution. By targeting and inactivating the bacterial DNA directly, irrespective of its sequence, mutations in the bacterial DNA don’t prevent SASP from working. Phico’s SASPject products can directly tackle the genetic cause of antibiotic resistance,” says Phico’s website.

“Our SASPject platform delivers pan-spectrum anti-bacterial proteins called small acid-soluble spore proteins, or SASPs, to selected bacterial species using targetable nano-delivery vehicles (NDVs). SASPject works by injecting a gene that encodes SASP directly into the targeted bacteria. The injected gene then produces SASPs, which bind to bacterial DNA and inactivate it. SASPs ‘turn off’ DNA so the targeted bacterial cell cannot metabolise or reproduce. The immune system can then remove the bacteria from the body.

“SASPs bind to all bacterial DNA, irrespective of the sequence of that DNA. Spontaneous mutations in DNA, or the import of new DNA that gives new characteristics to the bacterial cell, are key ways in which bacteria develop resistance to antibiotics. Neither of these strategies affects the ability of SASP to bind to and inactivate bacterial DNA.”

“This approach has the potential to provide a number of significant advantages over traditional antibiotics: the unique mode of action of SASP makes it unlikely the bacteria will be able to develop resistance to this anti-bacterial protein; SASPject technology can be used to target any selected bacteria, individual or multiple bacterial special or genera, including those that are multi-antibiotic resistant; unlike conventional antibiotics, SASPject has no effect on any bacteria other than those at which it is targeted - normal skin and gut bacteria are unharmed; SASPject target specificity prevents the release of toxins and other inflammatory cell components from non-target bacterial, thus potentially minimizing associated side effects; and SASPject has the potential to limit the further spread of antibiotic resistance genes and to shrink the current antibiotic resistance pool,” Phico’s website continues.

The Innovate UK funding will be used to improve the manufacturing yield of PT3.8. This includes the manufacture of a 15 liter pre-GMP batch for formal pre-clinical testing, and development of a quality management system (QMS) for manufacturing at Phico. As partners in the project, The Clinical Trial Company is developing the QMS and GE Healthcare advising on practical manufacturing processes. The program cost will total £2 million ($2.65 million USD), and the remaining funds will provided by Phico’s shareholders.

Dr Heather Fairhead, CEO at Phico said, “Our goal is to advance the science of antibacterial therapy to help overcome the global problem of bacterial resistance. This non-dilutive funding from Innovate UK is an important validation of our platform, and will enable us to take our lead product towards testing in humans.”